Clinical trials: Neuromuscular Diseases in Infants
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus, Poliomyelitis
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b
- Trial name
- NCT00871741
- Testing
- GSK2202083A vaccine, Infanrix hexa, Menjugate
- Where
- 8 sites in Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bacterial Infections, Virus Diseases
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
- Trial name
- NCT01340937
- Testing
- V419, PENTACEL™, Prevnar 13™
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Spinal Muscular Atrophy
Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy
In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants.
- Trial name
- STOPSMA (NCT00528268)
- Testing
- Sodium phenylbutyrate
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Utah
Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries.
- Conditions
- Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine, Shedding of Oral Rotavirus Vaccine
- Trial name
- NCT01616693
- Testing
- Probiotic, Zinc, Rotavirus vaccine
- Where
- India
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- PATH
Duchenne Muscular Dystrophy
Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy
While it has been known for many years that corticosteroid use benefits boys with Duchenne Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4 years of age.
- Trial name
- NCT02167217
- Testing
- Prednisolone
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Washington University School of Medicine
Poliomyelitis
A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of…
- Trial name
- NCT05677256
- Testing
- nOPV2
- Where
- Bangladesh
- Volunteers
- 501 people, healthy volunteers welcome
- Sponsor
- Fidec Corporation
Poliomyelitis, Tetanus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01309646
- Testing
- Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™
- Where
- 11 sites in South Korea
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4…
- Conditions
- Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
- Trial name
- NCT01248884
- Testing
- Infanrix hexa™, Prevenar 13®, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine.
- Trial name
- NCT01341639
- Testing
- V419, INFANRIX™ hexa, RotaTeq
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Cystic Fibrosis, Motor Neuron Disease
MN4000 for Treatment of CF and MND Patients in the Home Setting
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
- Conditions
- Cystic Fibrosis, Motor Neuron Disease, Airway Clearance Impairment
- Trial name
- NCT03797677
- Testing
- MN 4000
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
Poliomyelitis
IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
The purpose of this study is to select the optimal antigen dosage of the three Sabin poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent Sabin-based inactivated poliomyelitis vaccine…
- Trial name
- NCT03092791
- Testing
- Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV), Reference IPV
- Where
- 4 sites in Panama
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Takeda
Hepatitis B, Polio
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00362336
- Testing
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Where
- 2 sites in South Africa
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Poliomyelitis
Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.
- Trial name
- NCT02434770
- Testing
- BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1, BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2, BioFarma Bivalent Oral Poliomyelitis Vaccine
- Where
- 2 sites in Kenya
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- PATH
Diphtheria, Tetanus
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01177722
- Testing
- DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,375 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Spinal Muscular Atrophy
An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA)
An open-label, multi-part, first-in-human study of oral branaplam in infants with Type 1 spinal muscular atrophy. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD)…
- Trial name
- NCT02268552
- Testing
- branaplam
- Where
- 14 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Tetanus, Hepatitis B
Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT01090453
- Testing
- GSK2202083A vaccine, Prevenar 13®, Infanrix hexa™
- Where
- 34 sites in Canada, France and 1 more
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis
- Trial name
- NCT00325156
- Testing
- GSK Biologicals' combined DTPa-IPV/Hib vaccine
- Where
- Singapore
- Volunteers
- 2,590 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis, Tetanus
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT01353703
- Testing
- Infanrix hexa™
- Where
- 4 sites in India
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline